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FDA grants Fast Track designation to TTK inhibitor for the treatment of ER+/HER2- breast cancer
The designation seeks to streamline the development of new agents with potential to treat serious or life-threatening diseases
The US biotech company Treadwell Therapeutics has announced the FDA Fast Track designation of an inhibitor of Threonine Tyrosine Kinase for the treatment of patients with ER+/HER2- advanced breast cancer.
Globally, breast cancer is the world’s most prevalent cancer and the second leading cause of cancer death in women in many countries.
The ER+/HER2- subtype is the most common subtype of breast cancer, accounting for 68 per cent of all breast cancer types, with nearly 1.2 million women living with the disease in the US alone.
Standard of care for ER+ patients is CDK4/6 inhibitors in combination with endocrine therapies, which have been very successful in prolonging survival for this patient population.
However, resistance to this treatment occurs within a median of two years. As a result, the ER+ population resistant to this standard of care is growing and is an unmet medical need requiring new treatment options.
CFI-402257 is an orally active, highly selective small molecule inhibitor for TTK – the core component of the spindle assembly checkpoint – and can help adult patients with advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy.
“There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail,” said Dr Mark Bray, Treadwell CSO and co-founder.
“CFI-402257 [the TTK inhibitor] has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors.
“We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer.”
The FDA Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need.
Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.
Transdermal HRT best protects bone density in women with functional hypothalamic amenorrhoea, a condition that stops periods, a review of trials has found.
The meta-analysis pooled randomised clinical trials involving 692 participants and found transdermal hormone replacement therapy and teriparatide increased bone mineral density by between 2 and 13 per cent.
Functional hypothalamic amenorrhoea can follow anorexia or intense exercise. Bone mineral density measures bone strength and the amount of mineral in bone.
Around half of women with the condition have low bone mineral density, compared with about 1 per cent of healthy women, and their fracture risk is up to seven times higher.
The research was conducted by scientists at Imperial College London and Imperial College Healthcare NHS Trust.
Professor Alexander Comninos, senior author of the study and consultant endocrinologist at the trust, said: “Bone density is lost very rapidly in FHA and so addressing bone health early is very important to reduce the lifelong risk of fractures.
“Our study provides much needed comparisons of all the available treatments from all available studies.
“Clearly the best treatment is to restore normal menstrual cycles and therefore oestrogen levels through various psychological, nutritional or exercise interventions – but that is not always possible.
“The foundation for bone health is good calcium and vitamin D intake (through diet and/or supplements) but we have additional treatments that are more effective.”
When FHA is diagnosed, clinicians first try to restore periods through lifestyle measures, including psychological and dietary support, but these can fail. Guidelines then recommend giving oestrogen, though the best form was unclear.
The team reviewed all prior randomised trials comparing therapies, including oral and transdermal oestrogen, and also assessed teriparatide, a prescription bone-building drug used for severe osteoporosis.
They found no significant benefit for oral contraceptive pills or oral hormone therapy.
A recent UK audit reported that about a quarter of women with anorexia-related FHA are prescribed the oral contraceptive pill for bone loss; the study suggests using transdermal therapy instead.
Comninos said: “Our goal is simple: to help women receive the right treatment sooner and to protect their bone health in the long-term.
“We hope this study provides clinicians with better evidence to choose transdermal oestrogen when prescribing oestrogen and so inform future practice guidelines.
“Right now, millions of women with FHA may not be receiving the best treatments for their bone health.”
An AI tool cut interval breast cancers by 12 per cent in a Swedish screening trial of more than 105,000 women.
The study also found 27 per cent fewer aggressive breast cancers detected at screening when AI was used.
Interval cancers are cancers found between routine screening appointments because they were missed at the original scan. They are often more dangerous and linked to higher death rates than cancers found at screening.
The MASAI trial is described as the first large randomised study to test whether AI can improve mammography screening, which uses low-dose X-rays to examine breast tissue for signs of cancer.
The AI tool, called Transpara Detection and developed by ScreenPoint Medical, supported radiologists in analysing mammography images.
Earlier results from the same trial showed that Transpara Detection increased cancers found by 29 per cent and reduced radiologist workload by 44 per cent compared with standard double-reading, where two radiologists independently review each scan.
The latest findings indicate higher accuracy with AI support. Sensitivity, the ability to detect cancer, was 6.7 percentage points higher in the AI group while specificity, the ability to rule out healthy cases, was maintained. Results were similar across age groups and breast density levels.
Women screened with AI had 16 per cent fewer invasive interval cancers and 21 per cent fewer large interval cancers than those in the standard screening group.
The system also helps doctors assess risk more precisely by subdividing suspicious findings into BI-RADS 4 categories A, B and C. BI-RADS (Breast Imaging Reporting and Data System) is a standardised scale that guides whether a patient needs closer monitoring, further tests or treatment.
Ageing anxiety may accelerate biological ageing in women, with fears about worsening health linked to faster epigenetic ageing, according to new research.
The study found that greater anxiety about growing old was associated with accelerated epigenetic ageing, as measured by the DunedinPACE clock, based on biological markers in blood samples.
Epigenetic changes are shifts in how genes are switched on or off without altering DNA itself, which can influence how the body ages and functions.
“Our research suggests that subjective experiences may be driving objective measures of ageing,” said Mariana Rodrigues, a PhD student and the first author of the study.
“Ageing-related anxiety is not merely a psychological concern, but may leave a mark on the body with real health consequences.”
Researchers analysed data from 726 women in the Midlife in the US study.
Participants were asked how much they worried about becoming less attractive with age, having more health issues and being too old to have children.
Blood samples were used to assess ageing with two epigenetic clocks: DunedinPACE, which estimates the pace of biological ageing, and GrimAge2, which estimates cumulative biological damage.
The study was conducted by researchers at NYU School of Global Public Health.
Worrying about declining health showed the strongest links with epigenetic ageing, while anxiety about attractiveness and fertility was not significantly associated with biological markers.
The authors suggest health worries are more common and persist over time, whereas concerns about appearance and reproduction may fade with age.
“Women in midlife may also be multiple in roles, including caring for their ageing parents,” Rodrigues said.
“As they see older family members grow older and become sick, they may worry about whether the same thing will happen to them.”
The authors caution that the study offers a snapshot in time and other factors may influence these biological changes.
When analyses were adjusted for health behaviours such as smoking and alcohol use, the link between ageing anxiety and epigenetic ageing decreased and was no longer significant.
“Our research identifies ageing anxiety as a measurable and modifiable psychological determinant that seems to be shaping ageing biology,” said Adolfo Cuevas, associate professor of social and behavioural sciences and the study’s senior author.
They call for more research to clarify how this anxiety influences ageing over time, to guide support for those experiencing ageing anxiety.
“Ageing is a universal experience.” Rodrigues said.
“We need to start a discourse about how we as a society, through our norms, structural factors and interpersonal relationships, address the challenges of ageing.”
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